6 Amendments of Christofer FJELLNER related to 2012/0267(COD)
Amendment 121 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 195 #
Proposal for a regulation
Article 26 – paragraph 1 – subparagraph 2 (new)
Article 26 – paragraph 1 – subparagraph 2 (new)
Member States may decide that the assessment and monitoring referred to in the first subparagraph shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 208 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 1
Article 29 – paragraph 2 – subparagraph 1
The application shall specifybe accompanied by a description of the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Annex VI or supported by documentation proving compliance with all the requirements set out in Annex VI.
Amendment 209 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2
Article 29 – paragraph 2 – subparagraph 2
Amendment 272 #
Proposal for a regulation
Article 42
Article 42
deleted
Amendment 322 #
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b